NCT02521987

Brief Summary

The purpose of this study is to determine if there is a difference in pain perception by participants when the assistant port size varies by 50% (8 mm to 12 mm).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

July 24, 2015

Last Update Submit

January 30, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Participants will be asked to specify the point that represents their level of perceived pain intensity and mark it on the VAS at four time points.

    Measured with Visual Analog Scale (VAS) for pain at 1) baseline pain prior to the procedure in the pre-operatively holding area, 2) 4-6 hours post-operatively in the post-anesthesia care unit (PACU), 3) on post-operative day 1(POD1) and 4) once two weeks post operatively.

    2 weeks post-op visit

Secondary Outcomes (1)

  • What is the physician's perception of operative difficulty throughout the case? Determination of physician struggle and frustration will be documented.

    Day of surgery

Study Arms (2)

8mm Port

ACTIVE COMPARATOR

Participates will be randomized to have an 8 mm assistant port used during their surgery. The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1). The final pain assessment will be at the two weeks postoperative clinic visit.

Procedure: 8mm port

12mm Port

EXPERIMENTAL

Participates will be randomized to have an 12mm assistant port used during their surgery. The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1). The final pain assessment will be at the two weeks postoperative clinic visit.

Procedure: 12mm port

Interventions

8mm portPROCEDURE

Participate in this arm will have their procedure performed with an 8mm laparoscopic port.

8mm Port
12mm portPROCEDURE

Participate in this arm will have their procedure performed with a 12mm laparoscopic port.

12mm Port

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • laparoscopic surgery for pelvic organ prolapse.
  • proficiency in English .

You may not qualify if:

  • Not proficiency in English
  • Previous participation/randomization in the study at a previous visit
  • Pregnant women cannot participate
  • History of abdominal wall pain
  • Chronic pain patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (4)

  • Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. doi: 10.1097/01.AOG.0000136100.10818.d8.

    PMID: 15339758BACKGROUND

  • Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.

    PMID: 9083302BACKGROUND

  • Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.

    PMID: 19037026BACKGROUND

  • McDermott CD, Hale DS. Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep;36(3):585-614. doi: 10.1016/j.ogc.2009.09.004.

    PMID: 19932417BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth R Mueller, MD

    Loyola University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Associate Professor

Study Record Dates

First Submitted

July 24, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

November 16, 2017

Study Completion

November 16, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

US(1)